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临床试验/NCT05583903
NCT05583903已完成不适用

Usability and Acceptability of Virtual Reality-based Cognitive Stimulation by Healthy Participants

The Methodist Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start

研究概览

简要总结

This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.

详细描述

Virtual reality (VR) imitates reality by creating an artificial 3-D environment using computing technology or software. Using this software with a headset, a virtual environment is created, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a virtual environment allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled virtual environment. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. This trial aims to follow in similar footsteps using the gamification of exercises for cognitive stimulation in healthy volunteers to record outcomes and perform usability testing. These exercise "games" allow users to focus and pay attention to the game while helping reorient and cognitively stimulate the user's brain. The games are built with increasing difficulty and complexity of user demand and output. A novel, 3D-simulated software platform prototype called ''ReCognitionVR'' was developed to provide VR-based cognitive exercises to healthy participants for testing.

The premise of this trial is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed- environment with music.

According to our institutional review board recommendations, this pilot study will be conducted in two steps on two different cohorts which are as follows:

In the first step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercises will be evaluated on elderly healthy subjects. This study's results will inform the design of a second-step pilot study.

In the second step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercise will be evaluated for elderly surgical patients who are at high risk for the development of delirium.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-35 years or ≥60 years
  • Healthy volunteers who meet one of the following criteria according to their self-reported medical history:
  • American Society of Anesthesiologists (ASA) 1: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
  • ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (eg, treated hypertension, obesity with BMI under 35, frequent social drinker, but is nonsmoking).

排除标准

  • Age <18 years; 36-59 years
  • Person with active psychiatric disorders, especially schizophrenia
  • Person who is deaf or blind

研究组 & 干预措施

Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years

Experimental

Healthy volunteers between the ages of 18 and 35 years will utilize the ReCognition virtual reality software

干预措施: Virtual Reality Software (Other)

Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years

Experimental

Healthy volunteers 60 years of age and older will utilize the ReCognition virtual reality software

干预措施: Virtual Reality Software (Other)

结局指标

主要结局

Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start

时间窗: 20 minutes after the start of software use

Whether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome)

次要结局

  • Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use(Baseline and 10 minutes)
  • Participants With a System Usability Scale Score >35(After completion of use of the virtual reality software, up to 2 hours after the start of software use)
  • Participant High Score in Medium Difficulty Mode(After completion of use of the virtual reality software, up to 2 hours after the start of software use)
  • Participant High Score in Hard Mode(After completion of use of the virtual reality software, up to 2 hours after the start of software use)
  • Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use(Baseline and 10 minutes)
  • Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use(Baseline and the completion of the software game, up to 2 hours)
  • Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use(Baseline and the completion of the software game, up to 2 hours)
  • Participant High Score in Easy Mode(After completion of use of the virtual reality software, up to 2 hours after the start of software use)
  • Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use(Baseline and 10 minutes)
  • Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use(Baseline and 10 minutes)
  • Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use(Baseline and 10 minutes)
  • Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use(Baseline and the completion of the software game, up to 2 hours)
  • Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use(Baseline and the completion of the software game, up to 2 hours)
  • Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use(Baseline and the completion of the software game, up to 2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hina Faisal

Assistant Professor of Clinical Surgery

The Methodist Hospital Research Institute

研究点 (2)

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